instructions for use opton pro - medidor.ch · lower back pain (e.g. ischialgia) arthropathy,...

Instructions for Use

OptonPro

GB

Illustrations

Front of the device

Fig. 1

Selection and control elements

1 Controller 2 Display 3 Emergency stop button 4 Slot for SD card 5 On/off switch

Applicator with optical fibre 6 Applicator 7 Fibre-optic cable

Test sensor 8 Test sensor and bracket for applicator

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Illustrations

Rear of the device

Fig. 2

Connection sockets

9 Connection socket for foot switch 10 Connection socket for interlock socket 11 Connection for power cord 12 Holder for power fuse 13 Identification plate 14/15 Socket without function for OptonPro16 Fibre-optic output

9 10 11 12 13 14/15

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Illustrations

Display / Navigation bar

Fig. 3

Display 9 Status bar 10 Button on the screen 11 Title bar 12 Navigation bar

Fig. 4

Navigation bar Description of the functions

(A) Start Moves back to the start page (B) Back Takes you back one step (C) Key Activates key input (D) Performance test Switches to the calibration page (E) Memory Switches to the memory area (F) Indications Switches to the indication menu (G) Programs Switches to the programme list (H) Favourites Switches to the favourites area (I) Scroll backwards Moves back one page (J) Scroll forward Moves one page forward

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Illustrations

Accessories

22 Small spacer 23 Large spacer 24 Foot switch

25 Laser warning sign with laser warning lamp

26 Interlock plug 27 Protective sleeve

28 Laser protection glasses 29 Laser warning sign

Explanation of symbols

Caution laser outlet Note: Laser radiation is emitted from applicator tip

Turn the emergency stop button clockwise (following the arrows) to unlock

Application part type BF

Foot switch socket

Interlock socket

Value of accessible fuses

Protection class II

Instructions for use

Follow instructions for use

Serial number

Article number

Manufacturer

Date of manufacture

Caution In the instructions for use this symbol indicates „Caution“ with regard to possible damage of the device.

In the instructions for use this symbol indicates “Danger / Warning”.

Contents

Illustrations Front of the device Rear of the device Display / Navigation bars Accessories

Explanation of symbols Page

1 Indications 1

2 Contraindications 2

3 Side effects 3

4 Safety instructions/warnings 4

5 Application information 6

6 OptonPro – in brief 9

7 Device set-up 7.1 Safety precautions 7.2 Assembly and commissioning

10 11

8 Settings 12

9Operating instructions 9.1 Performing the treatment 9.2 Key code 9.3 Thermal threshold test 9.4 Two-phase programs 9.5 Storing programs 9.6 Favourites/memory list, retrieving programs, editing lists 9.7 Treatment recommendations

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Contents

10 Performance test 32

11 Key code 33

12 Technical data 34

13 Cleaning/disinfection 36

14 CE mark 38

15 Scope of delivery/accessories 39

16 Device combinations 40

17 Safety and maintenance 41

18 Functional test 42

19 Safety checks Metrological control

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20 Error messages/troubleshooting/disposal 44

21 Manufacturer´s EMC declaration 46

Valide for OptonPro devices. This instructions for use is an integral part of the device. It must be stored with the device and kept accessible at all times for anyone authorized to operate this device. The instructions for use is valid as of March 2015.

Indications 1

Page 1

OptonPro is used to initiate and support the healing of human tissues. The device is suitable for treating the following indications: Myopathy, tendinopathy Lower back pain (e.g. ischialgia) Arthropathy, arthrosis Rheumatoid arthritisTrauma disorders (e.g. distortion, strain) Impingement syndroms (e.g. carpal tunnel syndrome) Skin diseases (e.g. acne vulgaris, herpes simplex, verrucas, ano-genital warts, leg ulcers, and decubitus ulcers) The following effects have been demonstrated: Musculoskeletal disordersHealing, pain relief

Rheumatoid arthritisAlleviation, pain relief, increased mobility

Carpal tunnel syndrome Pain relief

TendinopathyAlleviation, pain relief, increased mobility

EpicondylitisHealing

Back and neck pain Pain relief

Chronic joint diseases Pain relief Practical experience has also shown that the device can have a positive effect in treating the following diseases: - Periarthropathia humeroscapularis - Adductor insertion tendinopathy - Patellar tendinitis - Major trochanteric tendinopathy - Achillodynia - Plantar fasciitis - Insertion tendinopathy of the pes anserinus - Painful muscular tension - Gonarthrosis - Rhizarthrosis - Cervical spondylarthrosis - Torn muscles - Morton’s neuroma

Contraindications 2

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- Fresh haematomas - Malignant, semi-malignant, and benign tumours - Treatments around the eye - Pregnancy - During menstruation in the abdomen or lower back Particular caution is advised when applying treatment near the ear, nose, mucous membranes, and blood vessels. Avoid direct irradiation of these areas. In the presence of skin diseases, metabolic diseases, and inflammatory diseases, a physician should be consulted prior to treatment.

Side effects 3

Page 3

When used correctly, no side effects are known.

Safety instructions/warnings 4

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The OptonPro is a class 4 laser. The laser radiation is extremely hazardous to the eyes and skin. Even diffusely scattered radiation can be dangerous. Laser radiation can cause fires or explosions. The laser radiation emitted by the device is invisible. Caution: the use of controls or settings options in a manner other than those described here may lead to hazardous exposure to radiation! Please observe all relevant safety instructions! The device must only be operated in accordance with occupational safety regulations and the rules of the relevant professional associations. The corresponding directives and regulations must be observed. The device may only be operated via a properly earthed socket with a grounded outlet (in accordance with VDE 0100 Part 710). The device may only be operated in accordance with these instructions. All other applications shall be the responsibility of the operator. For maintenance, extensions, readjustments, or changes, please refer to the national regulations. If there is any visible damage to the unit, the optical fibre, or applicator, the device must not be operated. Call customer service.

Legal requirements in accordance with the regulations of the BGV B2 (German Occupational Health and Safety Regulations of the trade associations, applies only within Germany)

1. Before first use, the commissioning of the device must be reported to the professional association and the competent authority for occupational safety (such as the trade supervision board).

2. The operator must appoint a laser safety officer. 3. The laser safety officer must provide safety instruction to all persons

involved in the use of the device. This training must be repeated annually. 4. The device may only be operated by trained personnel who are at least 18

years of age. All persons working within the area of the laser must be briefed on the rules of conduct and safety.

5. The area in which the laser is to be used must be identified with laser warning signage (e.g. on all doors to the treatment area). There must be warning lights on the doors that indicate when a laser is in use.

6. All doors to the laser treatment area should be secured with an interlock device. Other measures to protect against accidental irradiation are also allowed.

7. All objects and substances in the laser treatment area must be flame retardant.

8. Any instruments used in the laser treatment area must be designed in such a way as to prevent hazardous reflections.

This information has been taken from the BGV B2 and was valid at the time these operating instructions were printed. They are subject to change without notice.

Safety instructions/warnings 4

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General 1. The device is not intended for use in potentially explosive and/or combustive environments.

2. The use of flammable anaesthetic gases or oxidising gases such as nitrous oxide (N2O) or oxygen should be avoided. Some materials such as cotton, which are saturated with oxygen, can be ignited by the high temperatures that arise when the laser device is used. Adhesive solvents and flammable solutions used for cleaning and disinfection must be allowed to evaporate before the laser device is used. Attention should be paid to bodily gases, which may also ignite.

3. To avoid skin damage, please follow the treatment guidelines in the laser manual.

4. Please note that reflective objects in the treatment area can diffract the laser radiation.

5. Ensure that the laser treatment area is free of flammable substances.

6. Please note that the laser radiation can exit the treatment area via windows, glass doors, or other openings. Please take the appropriate precautions.

7. The fibre-optic cable and applicator are highly sensitive optical systems. Treat them with the appropriate care, and protect them from contamination.

8. Never bend the fibre-optic cable, and protect it against tensile loads. Damage to the fibre-optic cable can lead to unwanted exposure to radiation.

9. Under no circumstances should you unscrew the spacer sleeve on the front part of the applicator. A treatment without the spacer sleeve or with an incorrectly installed sleeve can lead to increased exposure to the laser beam and may cause skin burns.

10. When in use, electrical devices emit electromagnetic fields that may interfere with other devices. If in doubt, maintain sufficient distance from potential sources of interference, or avoid operating such devices simultaneously.

11. The device should only be used in the case of indication by a physician.

12. Caution – If operating/adjusting devices other than those described here are used or if other procedures are performed, these may result in hazardous radiation effects.

Application information 5

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Prior to using the device on the patient, the user should familiarize himself with the operating instructions and the individual treatment methods to be used, as well as with the indications, contraindications, warnings, and application information. Additional sources of information about the treatment should also be considered.

Caution! Before use, ensure that the device is operated via a properly grounded socket (electrical installation in accordance with DIN VDE 0100 Part 710). The device must only be operated with the power cable supplied. The power cable must be protected against mechanical stress.

Caution! Operating this device in the vicinity of strong electromagnetic fields (e.g. tomographs, x-ray or diathermy equipment) may interfere with the operation of the device. Please keep a safe distance of several meters. OptonPro should not be used in an explosive, flammable or combustive environment. When in use, the device must be located in a position that allows direct access to the central power supply so that it can be disconnected at any time. To avoid the risk of electric shock, the plug must be disconnected from the power supply before performing any cleaning or maintenance activities. Inspect the device before use. If there is any damage, the device must not be used.

Caution! Only accessories from Zimmer MedizinSysteme GmbH may be used.

Through electromagnetic effects, the device may cause malfunctions or interfere with the operation of other equipment in the surrounding area. It may be necessary to take appropriate remedial action, such as realigning or reassembling the device, or installing electromagnetic shielding.

Caution! The device may only be opened by authorised service technicians from Zimmer MedizinSysteme.


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Applicator The applicator is located at the end of the fibre-optic cable. Laser beam is emitted from the tip of the applicator. A lens protects the opening of the outlet against dirt and damage. Only aim the applicator at the area to be treated. Never place it down outside of the test sensor.

Foot switch The foot switch is used to initiate the laser beam. Only press the foot switch once the applicator has been aimed at the area to be treated. An acoustic signal sounds while the laser beam is being emitted. Position the foot switch in such a way that it cannot be activated accidentally or by unauthorised persons.

Emergency stop button

The emergency stop button enables an immediate interruption of operation by disconnecting the power supply. To interrupt operation, press the emergency stop button until it clicks and the device shuts down. To resume operation, return the button to its original position by turning the red knob in the direction of the arrows. Test sensor The test sensor enables the measurement and adjustment of the laser power. The applicator can be placed on the test sensor after treatment and when not in use. The applicator is protected against dirt and damage. Saftey glasses All individuals present in the treatment room (e.g. patient, therapist, and support staff) should wear the appropriate protective goggles. Only use goggles with an optical density OD > 3 at 810/980 nm and a translucence of at least 20% in the visible range. The goggles must be both heat- and UV-resistant and comply with the requirements of EN 207. Spacers There are two spacers available, each with a different length and treatment surface. These hold the laser head at a defined distance from the skin. Note that it may particularly lead to high power densities in the use of the handpiece without spacers and set high power power. There is a risk of thermal damage to the skin. Using the device without spacers is not recommended.

Protective sleeves Protective sleeves are available when the device is used without the spacers. They can be placed on the applicator to enhance patient comfort.

Silicone spacer (optional)

For the treatment of skin diseases, optional spacers made of silicone are available; these must be placed on the applicator to avoid contamination.

Note: For additional instructions on the use, cleaning, and disinfection of the spacer, please refer to the operating instructions.


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SD card Custom settings and treatment recommendations are saved on the SD card. Treatment

recommendationsIf no SD card is inserted, the “Treatment recommendations” button is not shown in the navigation bar. Favourites If no SD card is inserted and the favourites area is activated, the following message will appear: “SD card was not found”. Insert the SD card, and confirm with “OK”. Memory If no SD card is inserted and the memory area is activated, the following message appears: “SD card was not found. The use of the memory requires an SD card”. Insert the SD card, and confirm with “OK”.

OptonPro – in brief 6

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What is OptonPro? A high-power medical laser treatment device for treatment with laser radiation.

What does OptonProdo?

It emits laser beams to provide photochemical and thermal stimulation of those parts of the musculoskeletal system requiring physical treatment.

Why use OptonPro? The simultaneous use of laser beams of two wavelengths (810 and 980 nm) provides the user with a wide array of treatment options. The modern microprocessor control system and the precise equipment for measuring power facilitate the use of the device and minimise risks. The modern, clearly understandable colour display shows all parameters relative to the treatment, and the modern touch-screen controls facilitate treatment. Individual start-up settings as well as clear and simple menu navigation provide the user with the maximal comfort.

Note: The device may only be used by healthcare professionals (e.g. physicians, therapists, and trained medical assistants).

Device set-up

7.1 Safety precautions 7

Page 10

Safety measures Place a laser warning sign and a warning light on each door to the treatment room.

The laser safety officer must ensure that all safety measures have been correctly followed.

When not in use, the device should be protected against activation of the key button by unauthorised users.

Note: Make sure that the main switch of the device is set to “0”. Ensure that all individuals in the treatment room are wearing safety goggles. Make sure that the applicator (6) is fully inserted into the calibration sensor (8).

Device set-up

7.2 Assembly and commissioning 7

Page 11

Assembling the power cable

Connect the power cable to the corresponding socket (11) on the device, and connect the cable to the mains.

Interlock connector Connect the interlock plug (27) to the corresponding socket on the device (10).

Connect the foot switch

Connect the foot switch (27) to the corresponding socket on the device (10) and place it on the floor.

Attach spacer Insert the spacer (23/24) onto the applicator.

Switch on the device Turn on the device at the main switch.

Select programme Press the “Start” button, and select a program.

Activate key code Select the “Key” button, and enter the key code 1234.

Setting the beam intensity

Set the desired intensity.

Activate the laser Activate the laser by pressing the “Start” button.

Applicator Place the applicator in the correct position on the area to be treated.

Start of treatment The treatment starts once the foot switch has been activated.

End of treatment By de-activating the foot switch, the treatment is interrupted or terminated.

After treatment, remove the spacer from the applicator, and insert this into the test sensor.

Settings 8

Page 12

Note: The following descriptions are based on the factory default settings. All buttons, menus, and sub-menus can be activated directly on the screen by finger pressure. Ensure that all individuals in the treatment room are wearing safety goggles. To prevent unauthorised persons from using the laser, the OptonPro must be activated by entering a key code each time it is switched on and off.Only once the code has been entered can the laser beam power be adjusted and emitted. Changes to the default settings are only possible from the start-up screen.

Start-up screen

Selecting the configuration

Activating the “Settings” button (1) opens the “Settings” screen.

Settings In the settings menu, the factory default settings can be individually changed and adjusted. After activating the Settings, the “Settings” screen is active.

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Settings 8

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The setting options are shown below. In the factory, the default settings are pre-programmed as shown on the screen.

(1) Language Press the “Language” button to open the window for selecting the language. The selection is made directly on the corresponding line.

(2) Laser settings Press the “Reminder for performance test” button to open a window with various options that provide a reminder for conducting the performance test. The selection is made directly on the corresponding line. 1. Activated: If 10 hours of treatment are exceeded without conducting a

performance test, the message “The last performance test was conducted more than 10 hours ago. It is recommended to conduct a performance test” will be displayed with every start-up of the device.

2. Once: If 10 hours of treatment are exceeded without conducting a performance test, the aforementioned message will be displayed on the next device start up.

3. Deactivated: There is no message about conducting a performance test in general

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Settings 8

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(3) Start-up settings 1. Start menu: Individual options for start settings. 2. Start-up image: Choice between two starting images. The selection is made directly on the corresponding line. 3. Welcome:Activation of the field "Welcome" opens a window with an alphabetic keyboard for entering a custom welcome message on the start-up screen. Pressing the “OK” button saves the text that has been entered. Pressing the “Cancel” button returns to the configuration menu.

(4) Audio/graphics

settings volume 1. Brightness: Allows the brightness of the screen to be adjusted. 2. Volume: Allows adjustment of the volume of the signal tones that occur when activating the control fields. The adjustment is made using two arrow keys.

(5) OK Pressing the “OK” button switches to the start-up screen.

(6) Version Pressing the “Version” button opens a window with information about the current software version.

(7) Touch Calibration Depending on the model, the “Touch Calibration” button may be available. If the button is not available, the touch calibration is done automatically so that the user does not have to worry about it. If the "touch calibration" button is present: Pressing the “Touch Calibration” button opens the screen to perform a touch calibration. In the case of insufficient accuracy during the touch entry, this can lead to an improvement. For the touch calibration, follow the on-screen instructions.

(8) Key Allows individual key codes to be set. Pressing the “Key” button opens a number pad for entering the code. To specify a custom key code, the previous key code must first be entered on the keypad. Pressing the "OK" button triggers the message to enter a new four-digit key code, and the cursor automatically jumps to the "New key" field. The new key code can be entered using the number keypad. Press "OK" to accept and close the keypad. Pressing the "Cancel" button cancels the operation.

Settings 8

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(9) Deactivating access

Individual adjustment of the deactivation period. The adjustment is made using two arrow keys. Setting "deactivate” invalidates the default or custom-fitted activation time.

Note: Each time the OptonPro is switched on, the key code must be entered. This also applies to the “Deactivated” setting.

(10) Standard Pressing the “Standard” button restores the default factory settings.

Note: The “Maintenance” menu is only accessible to service technicians.

(11) Pilot beam Pressing the “Pilot beam” button opens a window with various options for using

the pilot beam. Deactivated: The pilot beam is not activated. At laser “active”: Pilot beam is active when laser power is emitted. At laser “ready”: Pilot beam is active when the laser has been made

operational by pressing the “Start” button.

Note: If the pilot beam is in the “ready” mode, the pilot beam becomes inactive as soon as the laser is no longer operational, e.g. by “Saving” or opening the parameter window.

Note: If the laser treatment device is not equipped with a pilot beam, this button is not present.

Note: The pilot beam only provides information about the direction of the laser beam. It does not correspond to the diameter of the laser beam and is not an indicator for the size of the treatment field.

Save settings Pressing the “OK” button saves the changed settings and returns to the start-up screen.

Operating instructions

9.1 Performing the treatment 9

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Starting the programme

Pressing the “Start” button in the start-up screen opens the programmes screen.

Programme screen

The selection of the desired program is made directly on the line.

Operating modes The following operating modes can be selected: - Unpulsed - Single pulse - Serial pulse - Burst Available options in

the various operating modes

Single pulse: - Pulse time 0.1–5 s

Frequency Duty cycle

Serial pulse / burst: 0.1–1 Hz. 2, 4, 5, 10 Hz 1:1–1:10 Serial pulse: 25 Hz 1:1–1:3 Serial pulse: 50 Hz 1:1 Burst pulses: 1–100



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Setting the operating modes

Pressing the “Parameter” button (1) opens the “Parameter” window. Here you can select the settings for the different operating modes.

Use the button (2) to select the parameter to be changed. Use the button (3) to set the respective values. Pressing the button (4) accepts the changed settings. Pressing the button (5) cancels the operation.

Setting the desired parameters

Pressing the “Set parameters” button opens the “Rated parameters” window

Input reminder / total energy

Pressing the “Remember” (1) and “Total energy” (2) buttons opens an “Input” window. Use the cursor to select the desired decimal place. Enter the desired values via the numeric keypad.

Pressing the “OK” button accepts the changed settings. Pressing the “Cancel” button cancels the operation.

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Reminder In the input field (1) it is possible to enter a certain number of joules. After the set number of joules is given, an acoustic signal sounds. Depending on the number of Joules entered, the signal is repeated at equal intervals until the target total energy is achieved.

If no target total energy has been entered, you will hear a single beep after the set number of Joules has been given.

Total energy In the “total energy” input field (2), it is possible to set a target total energy. After the target total energy is emitted, an audible signal sounds, and the laser application is interrupted. The application can be continued by pressing the foot switch again.

Note: It is not required to set a reminder and a target total energy for treatment. Recommendation To determine the correct individual laser power, it is recommended to perform

a thermal threshold test before each treatment (Chapter 9.3).



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Use the arrow keysto adjust the power

There are several options available for setting the power: Using the arrow keys (1) on the underside of the bar graph, the power can be adjusted in 0.1 W increments.

Setting power via the selection field

Activating the bar graph (1) opens the “Input power” window (2). The selection is made by pressing the button with the desired power (3). The setting is adjusted in increments of 1 W. Pressing the “OK” button accepts the selected power. Pressing the “Cancel” button cancels the operation.

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Setting the power via the numeric keypad

The numeric keypad (1) is found in the "Input power" window.

Activating the number field (1) opens another “Input” window (2).

The desired power is entered via the numeric keypad (3). The black shaded digit is changed when you select a number key. After setting the first place, the black mark will automatically move to the second place. Using the arrow keys (4), the digit to be set can be selected manually.

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Activate laser Pressing the “Start” button prepares the laser for operation.

This is indicated by the message “Ready” in the footer. The “Start” button is inactivated, and the “Stop” button is activated.

Start of treatment By pressing the foot switch, the laser beam is emitted, and the “Ready” message switches to “Active”.

In the bar graph, the current power wattage is displayed. Note: During the treatment, the patient must be monitored carefully. If any issues arise, the treatment should be adjusted or terminated.



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End of treatment The power of power is terminated when the foot switch is deactivated or the total energy has been reached. The message in the footer switches from "Active" to "Ready".

The power must be manually set to 0.0 W. You can set the value via the two arrows at the bottom of the bar graph. Alternatively, you can select the bar graph following the number pad and enter the value using the numeric keypad. Upon completion of the treatment, remove the spacer from the applicator. Insert the applicator into the calibration sensor.

Note: If the power is interrupted via the “Stop” button, the message “Please activate the laser with start” will appear in the status bar. If activation is performed, the display in the status bar to changes to “Ready”, and the laser is once again ready for operation. To prevent the laser from being used by unauthorised persons, it is best to block access after each treatment. This is done by pressing the “Key” button. The deactivation is symbolised by a red X on the “Key” button. If you disable access following a treatment, be sure to activate it before the next treatment by re-entering the key code.


9.2 Key code 9

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Note: It is recommended to activate the key code in the program screen. If the key code is first activated in the treatment screen, the treatment screen will be disabled, and it will not be possible to enter the intensity.

Activating the key code

Pressing the “Code” button (1) opens a window to enter the code number.

Enter the factory-set code (1234) or your own code (which you programmed in the configuration menu), and confirm with the “OK” button.

After activating the code, the symbol on the key button (2) changes, and the message “Please activate the laser using Start” is displayed in the footer.

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9.3 Thermal threshold test 9

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Note: The thermal threshold test is recommended to prevent overdose for darker skin types (skin type IV, V, VI), especially in CW mode. The thermal threshold test requires an intact thermal sensitivity. If it is locally disturbed, the test should be carried out on a heat-sensitive spot.

For this purpose, the laser beam is applied until the patient detects the heat. If the application is between 7 and 11 s, the proper laser power is set.

Pressing the “Thermal threshold” button (1) opens the window for performing the thermal threshold tests (2).

The thermal threshold test is performed in non-pulsed mode, which is automatically set after pressing the “thermal threshold” button.

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9.3 Thermal threshold test 9

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Performance The laser power is now set at the discretion of the user and is emitted by pressing the foot switch. During the emission of the laser power, the elapsed time in the bar graph (3) is displayed in the thermal threshold test window. If the patient senses a thermal effect, the laser emission is stopped by deactivating the foot switch. If the duration of emission exceeds 11 s, a message will appear, and the power will be increased by 0.5 W. If the emission falls below the duration of 7 s, a message will appear, and the power will be decreased by 0.5 W. The thermal threshold test is then repeated with the adjusted power. If the test is discontinued between 7 and 11 s, the recommended power is determined. This is indicated by a message. By selecting the “thermal threshold” window, the test mode is terminated. The measured laser power is saved, and the original operating mode is restored.

Note: If the thermal threshold is determined to be between 0.5 and 0.1 W and the thermal effect is achieved in under 7 s, the power is reduced by 0.1 W.


9.4 Two-phase programme 9

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Two-phaseprogramme

The laser power can be applied statically and dynamically. It is recommended to use both methods in succession during a session.

Note: The trigger and main pain points are thus treated statically, and the remaining pain areas are treated dynamically. In the programme list, programmes with two phases are integrated. This should facilitate both dynamic and static applications during a treatment session.

The phases can be switched by activating the two keys (1). The set values are retained during a switch. The actual total energy is maintained when switching the phases.

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9.5 Storing programmes 9

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Note: To store programmes, the SD card must be properly inserted into the SD card slot. If this is not the case, it will not be possible to save programmes. The programmes can also be saved unchanged. In the treatment screen, the programme parameters can be modified and saved.

Saving and namingthe programme

Pressing the “Save” button (1)

opens the field for entering the programme name.

The programme name is entered via the keyboard.

(1)


9.5 Storing programmes 9

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The parameters of the pre-defined programmes can be individually modified and saved.

Save and name a programme

Pressing the “Save” button opens a window to enter the programme name.

The programme name is entered via the keyboard.

Note: The programmes can be saved in the favourites list or in the memory list. There are 120 memory locations available for each.

Saving in the favourites list / memory list

Pressing the "Favourites" button (1) opens the list of favourites and automatically enters the programme in the favourites list. Pressing the "Memory" button (2) opens the memory list and automatically saves the programme to the memory list. Pressing the "OK" button closes the "Edit favourites" or "Edit memory" screen and returns to the therapy screen. The programme is always stored in the first available spot of the list. The programme name is displayed in the title bar. Pressing the "Cancel" button (3) interrupts the storage process.

Note: If the “Memory” button is been pushed without entering a programme name, the following message will appear: “Please enter a name!” Confirm the message with “OK”, enter the programme name, and repeat the saving process.

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Operating instructions9.6 Favourites/memory list

Retrieving programs, editing lists 9

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The individually saved programmes are listed in the favourites list. These can be: 1. retrieved for treatment 2. edited (shifted in the sequence and deleted).

Note: The steps for retrieving and editing the favourites/memory list are identical; therefore, only the retrieval and editing of the favourites list is described.

Selecting favourite list

Pressing the “Favourites” button opens the list of favourites.

Opening the programme

The selection of the desired programme is made directly on the line.

Edit favourites list

By activating the buttons (1) and (2), the individual favourite pages can be viewed. The button (1) scrolls forward, and the button (2) scrolls backwards. Pressing the button (3) opens the "Favourites" screen. The favourites to be edited are selected directly in the line.

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Operating instructions9.6 Favourites/memory list

Retrieving programs, editing lists 9

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Editing favourites

Pressing the button (1) returns you to the programme. Pressing the button (2) moves the programme to the top. Pressing the button (3) moves the programme to the bottom. Pressing the button (4) deletes the programme.

Note: Pressing the button (4) triggers a confirmation request: "Do you really want to delete this programme?" Pressing the "yes" button deletes the programme. Pressing the "No" button cancels the deletion.

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9.7 Treatment recommendations 9

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The “Treatment Recommendations” menu helps users to select the appropriate treatment options.

Treatment Pressing the “Treatment” button opens the “Treatment recommendations” menu.

Note: In the “Therapy” menu, there are two ways of selecting the desired treatment: - via the body region - via the list

Therapy selection via body region

Select the body region by clicking on the corresponding red circles.

Selecting the body region

After selecting the desired region of the body (here the shoulder), the window for applications in the shoulder area will open.

The selection is made directly on the corresponding line.


9.7 Treatment recommendations 9

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Therapy selectionvia list

Pressing the “List” button opens the list of indications.

Note: Regardless of whether the application is selected via body region or list, the program steps up to the treatment screen are identical and are therefore only described once below.

Selecting a differentiated clinical picture

The selection of the differentiated clinical picture is made directly in the corresponding line.

Therapy programme If the selection is completed, the therapy programme opens with

recommendations for treatment type and the amount of energy.

The parameters of the pre-defined programs can be individually modified and saved.

(1)

Performance test 10

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The performance test is used to control the emitted laser power. It should be performed once daily before the first use of the laser.

Procedure 1. Activation of the button “performance test”. 2. If necessary, enable the laser by entering the key code. 3. Close doors if interlock is installed. 4. Make sure that the laser hand piece is in the calibration unit. 5. Activate the laser via Start. 6. Entry of the maximal laser power. 7. Press the foot switch for the specified duration.

During the calibration, the elapsed time is shown in the bar graph in window (3). Results of

performance test The results of the performance test are displayed in window (1). 1. Performance test OK: Laser is operating normally. 2. Limited accuracy: The laser shows a deviation in laser power. This indicates soiling or age-related deviations of the laser system. The device can continue to be used, but maintenance should be performed within four weeks. 3. Performance test failed: The laser power is outside of the allowable range. The device must not be used. Decommission the device, and contact your service representative. The power test can be repeated by selecting the reset button (4). The test sensor must cool down before the performance test can be repeated. This is signalled by a message in the status bar.

The execution of the last power test is displayed in window (2).

1

2

3

4

Key code 11

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The laser is protected by a key code, which must be entered each time the device is switched on.

Note: If access is disabled, only the parameters can be set. Activating the laser via the “Start” button, setting the power, and calibration are not possible.

Correctly entering the key code

If an incorrect key code is entered, this is indicated by the following message.

After confirming with the “OK” button, the entry may be repeated.

Automaticdeactivation of the key code

The access is automatically disabled after 10 minutes if no adjustments are made within this time. The key code must then be re-entered. If operations are performed within the 10 minutes, the deactivation period will automatically reset to 10 minutes.

Note: In the configuration menu (Chapter 8), it is possible to define your own key code and customise the deactivation times.

Technical information 12

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Wavelength 810 nm and 980 nm

Wavelength of pilot beam 650 nm

Power supply 100–240 V~, 50/60 Hz 220 V ~/60 Hz

Power consumption max. 200 VA

Mains fuse 2 × T 2A

Protection class II Application part Type BF in accordance with EN 60601-1

Laser system 4 semi-conductor diode lasers, optical fibres

Treatment field min. Ø 10 mm

Output Power max. 7 W

Output Power Pilot beam

max. 5 mW

Repetition frequency 0.1 to 1 Hz, 2 Hz, 4 Hz, 5 Hz, 10 Hz, 25 Hz, and 50 Hz (CW mode)

Pulse duration 0.1 to 5 s (pulse mode)

Accuracy ±20%

Without spacers Small spacer Large spacer

Treatment distance 0 cm 1.2 cm 4.5 cm Treatment area min. Ø 10 mm/0.8 cm² min. Ø 20 mm/3.1 cm² min. Ø 34 mm/9 cm² Output density max. 9 W/cm² max. 3.5 W/cm² max. 1.1 W/cm²

Small spacer L 1.2 cm

Large spacer L 4.5 cm

Output density without spacers

max. 9 W/cm²

Output density with small spacer (1.2 cm)

max. 3.5 W/cm²

Output density with large spacer (4.5 cm)

max. 1.1 W/cm²

Technical information 12

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Dimensions H 30 × W 35 × L 20 cm

Laser class 4

Safety distance NOHD (nominal ocular hazard distance) 1.66 m

Beam divergence 35°

Interlock device Door contact switch, open when door is opened, load up to 12 V, 10 mA, series circuit in the case of several doors

Display Liquid crystal display (LCD)

Weight Total: 3.8 kg

Environmentalconditions

Operation: Temperature: 10°C…40°C Humidity: 30…90% relative humidity, no condensation Air pressure: 700…1060 hPa Storage and transport: Temperature: 10°C…50°C Humidity: 10…90% relative humidity, no condensation Air pressure: 700…1060 hPa

Storage and transport Please keep all packaging. The device may only be shipped and stored in the original packaging.

Cleaning/disinfection 13

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– Before starting any maintenance or cleaning measures, the device must be switched off with the main switch, and the power cable must be unplugged. – Make sure that when cleaning and disinfecting the labels of the device (such as warnings, labels of control devices, identification plate) are not damaged. –Make sure that during cleaning and disinfection no liquids penetrate the device, food switch or applicator. Do not use sprays. - If during cleaning or disinfecting liquid penetrates the device, please put the unit out of service, protect it from being used again and contact your service representative. – The device and its applied part are not considered critical in relation to hygiene when used on non-injured and healthy skin.

Housing /foot switch

Cleaning: In the event of visible contamination the housing, the foot switch, and all cables can be cleaned using commercially available alcohol-free cleaning agents designed for plastic. Wipe the surface with a soft cloth soaked in the cleansing agent (but not dripping) according to the manufacturer's instructions until the dirt is removed.

Disinfection: We recommend disinfecting the device at least once a week or upon indication of contamination. Please consult your hygiene professional. Always clean the device before disinfecting it. The housing and foot switch can be disinfected with disinfectant wipes. Use a commercially available alcohol-free disinfectant for metal and plastics that has a bactericidal, virucidal, and fungicidal effect. Observe the application instructions provided by the manufacturer. Wipe all surfaces with a soft cloth soaked (but not dripping wet) according to the specifications of the manufacturer of the disinfectant or with cloth pre-impregnated with disinfectant (wipes). Follow any instructions for drying or post-cleaning.

Applicator / spacers Cleaning: Remove the spacer from the applicator before cleaning. Then proceed as indicated under "Housing / Foot switch". Use a cotton swab to clean the applicator lens.

Disinfection: We recommend disinfecting the device at least once a week or upon indication of contamination. Please consult your hygiene professional. Always clean the device before disinfecting it. Remove the spacers from the applicator before cleaning. Use a commercially available alcohol-free disinfectant for metal and plastics that has a bactericidal, virucidal, and fungicidal effect.

Cleaning/disinfection 13

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Then proceed as indicated under "Housing / Foot switch". Use a cotton swab to clean the applicator lens. Absolutely no cleaning or disinfectant agent must be left on the applicator lens! Any contamination will change the optical properties of the lens. Contact the service department in such a case.

Caution: If flammable solutions are used for cleaning and disinfection, enough time must be allowed for them to evaporate before using the device. This may otherwise result in ignition!

Note: Only use the device in a hygienic environment.

CE mark 14

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The product bears the CE mark

in accordance with EC directive 93/42/EEC concerning medical devices.

Scope of delivery and accessories 15

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Scope of delivery Article no.* 1 Basic unit 1 Power cable 1 Foot switch 1 Interlock plug 2 Sets of safety glasses 1 Laser warning sign for door incl. warning light 1 Small spacer 1 Large spacer 25 Protective sleeves 1 Instructions for use *see accessories

Accessories Article no. 117 Power cable 94119055 Foot switch 98072210 Safety device for door monitoring 68072310 Interlock plug 87450250 Safety glasses 95730012 Laser warning sign for door incl. warning light 50400240 Small spacer 50400250 Large spacer 65071610 Silicone spacer 65730310 Protective sleeves (25 pcs.) 10101670 Instructions for use

Device combinations 16

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For OptonPro no combination devices are provided by the manufacturer. Anyone who contrary to these specifications combines devices and thus operates a medical system does so at its own risk.

Safety and maintenance 17

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The OptonPro is manufactured in accordance with the DIN EN 60601-1 safety regulations. Zimmer MedizinSysteme GmbH shall only be held responsible for the safety and reliability of the device if

the device is operated using a proper power outlet with earth contact, the electrical installation complies with DIN VDE 0100 part 710

the device is operated in accordance with the instructions

extensions, readjustments, or modifications are only performed by persons authorised by Zimmer MedizinSysteme GmbH

the user has been instructed in the functional safety, proper operating condition, and the mechanical integrity of the device and hand piece prior to use

the device is only operated by properly trained personnel

the device is not operated in hazardous areas and/or a combustive atmosphere

the device is immediately disconnected from the mains supply upon penetration by liquid

The device contains no parts that can be maintained by the operator orrepaired.

Performance test It is advisable to conduct a performance test of the laser system before each treatment. This will ensure that the laser system is operating properly, that the laser cable is intact, and that the applicator is functional.

Functional test 18

Page 43

Note: Ensure that all individuals in the treatment room are wearing safety glasses. Implementation 1. Conduct a performance test (Chapter 10).

2. Press the emergency stop button. The device must switch off immediately.

Return the button to its original position by turning the red knob in the direction of the arrows.

Safety checks Metrological checks 19

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In Germany, neither a safety check nor a metrological check is required for the OptonPro. The device is neither assigned to Appendix 1 nor Appendix 2 of the MPBetreibV (Medical Device Operator Ordinance). In Germany, the MPBetreibV Medical Devices Operator Ordinance and BGV B2 (German Occupational Health and Safety Regulations on Electrical Systems and Equipment) apply in their current versions.

Note: These requirements apply to the operation of the unit in Germany. Please observe the national regulations in your country.

ErrorsTroubleshootingDisposal 20

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Malfunction of the device

No response to the main switch; the display remains dark. Possible cause 1: Mains connection Remedy for cause 1: Check whether the power cable is properly plugged into the electrical outlet and the plug is firmly inserted into the socket of the device. Check the power cable for damage. Check the power grid and the outlet. Possible cause 2: Mains fuse Remedy for cause 2: Check the mains fuse. Replace the fuse only with the same or equivalent fuse. Before starting, completely check power supply for possible errors.

If the fault occurs again, inform customer service. Possible cause 3: The emergency stop button has been pressed. Remedy for cause 3: Check whether the emergency stop button has been released. Laser emits no power Possible cause 1: Interlock plug Remedy for cause 1: Check whether the interlock plug has been correctly installed.

If a door sensor has been installed, check whether the door is open or not closed properly. Possible cause 3: Foot switch Remedy for cause 3: Check whether the foot switch has been correctly installed. The applicator

temperature is too lowThe unit is too cold. Wait until the operating temperature has been reached as indicated by a message on the display. The applicator

temperature too high The device has become overheated through extended periods of high laser power. Wait until the operating temperature has been reached as indicated by a message on the display.

ErrorsTroubleshootingDisposal 20

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Malfunction Internal device malfunctions are indicated by an error message on the display. Malfunctions can sometimes be fixed by switching off the device, waiting 5 seconds, and then switching the device back on. If this does not work, please contact customer service. You can reach the service department via your sales representative or by calling our Neu-Ulm office. Customer service If there are frequent malfunctions or if they cannot be resolved as described above, please inform customer service. You can reach the service department via your sales representative or by calling our Neu-Ulm office. Headquarter Zimmer MedizinSysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm Tel. 0731. 9761-0 Fax 0731. 9761-118 www.zimmer.de Disposal The device may only be returned to the factory in the original packaging. It must be disposed of by Zimmer MedizinSysteme GmbH. In foreign (European) countries, please refer to national regulations for disposal. Contact your distributor if necessary.

EMC manufacturer’s declaration 21

Page 47

Medical devices such as the OptonPro are subject to special precautions with respect to electromagnetic compatibility (EMC) and must be installed and operated according to the user manual or the EMC instructions included with the device. Portable and mobile RF communications equipment (such as mobile telephones) can affect electrical medical devices. The OptonPro may only be used with the original parts specified in the list of delivery and accessories. The operation of the device with other parts may result in increased emissions or decreased resistance of the device!

Guidelines and manufacturer’s declaration – electromagnetic interference emissions The Device OptonPro is intended for use in one of the electromagnetic environments specified below. The customer or the user of the OptonPro should ensure that it is only used in such an environment.

Interference emission measurements Accordance Electromagnetic environment – Guidelines RF emissions in accordance with CISPR 11 Group 2 The OptonPro must emit electromagnetic

energy in order to perform its intended function. Neighbouring devices may be affected.

RF emissions in accordance with CISPR 11 Class B The OptonPro is suitable for use in establishments other than residential areas as well as those that are directly connected to the public supply network that supplies residential buildings as long as the following warning is observed: Warning: This device/system is only intended for use by medical professionals. This is a Class A device/system in accordance with CISPR 11. In residential areas,this device/system may cause radio interference. In this case, it may be necessary to take suitable remedies such as new alignment, new layout, shielding of the OptonPro, or filtering the connection to the site.

Emissions of harmonic oscillations in accordance with IEC 61000-3-2

Class A

Emissions of voltage fluctuations/flickers in accordance with IEC 61000-3-3

Conforms with

Table 201 in accordance with EN 60601-1-2:2006-10 The device must not be used adjacent to or stacked directly on top of other devices. If it must be used in the vicinity of or stacked directly on top of other devices, the device should be monitored to verify that it is operating properly in this configuration.


Page 48

Guidelines and manufacturer’s declaration – electromagnetic interference emissions The OptonPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the OptonPro should ensure that it is only used in such an environment.

Interference checks IEC 60601 – Test level

Compliance level Electromagnetic environment – guidelines

Electrostatic discharge (ESD) in accordance with IEC 61000-4-2

±6 kV contact discharge ±8 kV air discharge

±6 kV contact discharge ±8 kV air discharge

Floors should be made of wood, concrete, or ceramic tile. If the floors are covered with synthetic materials, the relative air humidity must be less than 30%.

Electrical fast transient/bursts in accordance with IEC 61000-4-4

±2kV for power supply lines ±1 kV for input and power lines

±2kV for power supply lines Does not apply

The quality of the supply voltage should correspond to that of a commercial or hospitalenvironment.

Impulse voltages (surges) in accordance with IEC 61000-4-5

±1 kV phase conductor to phase conductor ±2 kV phase conductor to earth

±0.5 kV differential voltage ± 1kV common mode voltage

The quality of the supply voltage should correspond to that of a commercial or hospitalenvironment.

Voltage dips, short interruptions, and voltage variations in accordance with IEC 61000-4-11

<5% UT (> 95% dip in UT for ½ period) 40% UT (60% dip in UT for 5 periods) 70% UT (30% dip in UT 25 period) <5% UT (> 95% dip in UT for 5 seconds)

<5% UT (> 95% dip in UT for ½ period) 40% UT (60% dip in UT for 5 periods) 70% UT (30% dip in UT 25 period) <5% UT (> 95% dip in UT for 5 seconds)

The quality of the power supply should correspond to that of a typical commercial or hospital environment. If the user of OptonPro wishes to continue operation even after the energy supply is interrupted, it is recommended that the OptonPro be connected to an

uninterruptible power supply (UPS) battery.

This may cause the device to reset.

Note: UT is the mains AC voltage before application of the test level.

Table 202 in accordance with EN 60601-1-2:2006-10


Page 49

Key features the OptonPro are: the emission of laser radiation for therapeutic purposes as well as the trouble-free operation of all functions.

Guidelines and manufacturer’s declaration – electromagnetic interference emissions The OptonPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the OptonPro should ensure that it is only used in such an environment.

Interference tests

IEC 60601 – test level

Conformity level

Electromagnetic environment – guidelines

Conducted RF interference in accordance with IEC 61000-4-6 Radiated RF disturbances in accordance with IEC 61000-4-3

3 VRMS 150 KHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3 VRMS 150 KHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

Portable and mobile RF communications equipment (including cables) should be used no closer to the OptonPro than the recommended separation distance, which is calculated according to the equation for the transmission frequency. Recommended separation distance:

d = 1.17 P

d = 1.17 P for 80 to 800 MHz

d = 2.33 P for 800 MHz to 2.5 GHz where P is the nominal rating of the transmitter in watts (W) in accordance with the manufacturer of the transmitter and d is the recommended separation distance in metres (m). In accordance with an on-site investigationa, for all frequencies, the field strength of a stationary radio transmitter should be less than the coincidence levelb. In the vicinity of devices marked with the following symbol, errors may occur:

NOTE 1: At 80 Hz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all cases. The spread of electromagnetic variables is affected by the absorption and reflection of structures, objects, and people.

a The field strengths of fixed transmitters e.g. base stations of mobile telephones and mobile radio devices, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be accurately predicted. To assess the electromagnetic environment with respect to fixed RF transmitters, an electromagnetic survey of the site should be considered. If the measured field strength in the location in which the OptonPro is used exceeds the applicable RF compliance level, the OptonPro should be observed in order to verify normal operation. If abnormal power is observed, additional measures may be necessary e.g. reorienting or relocating the OptonPro. b In the frequency range of 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.


Recommended separation distances between portable and mobile RF communications equipment and the OptonPro


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The OptonPro is intended for use in one of the electromagnetic environments specified below. The customer or the user of the OptonPro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OptonPro – depending on the power power of the communications equipment as specified below.

Nominal capacity of the transmitter W

Protective distance dependent on the transmission frequency M

150 KHz to 80 MHz d = 1.17 P

80 to 800 MHz d = 1.17 P

800 MHz to 2.5 GHz d = 2.33 P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.67 11.67 23.33

For transmitters for which the maximum nominal power is not specified in the above table, the recommended separation distance d in meters (m) can be determined using the equation given for the corresponding column, where P is the maximum rated power of the transmitter in watts (W) in accordance with the manufacturer of the transmitter. NOTE 1: At 80 and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all cases. The spread of electromagnetic variables is affected by the absorption and reflection of structures, objects, and people.


OptonPro

Zimmer MedizinSysteme GmbH

Junkersstraße 9

D-89231 Neu-Ulm

Tel. +49 731. 97 61-291

Fax +49 731. 97 61-299

[email protected]

www.zimmer.de

Instructions for Use

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